14 June 2017
Oxford BioMedica Notes Findings on CTL019 from Phase II JULIET Study Presented at the 14th Meeting of International Conference on Malignant Lymphoma (ICML)
Oxford, UK – 14 June 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes the findings reported by Novartis on its global multi-centre Phase II JULIET study evaluating the efficacy and safety of CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The study met its primary objective at interim analysis.
Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. The commercial launch of CTL019 is anticipated by Novartis later this year and Oxford BioMedica will receive undisclosed royalties on potential future sales of Novartis CAR-T products.
The findings were presented during an oral session at 15:40 CET on Wednesday 14th June 2017 at the 14th International Conference on Malignant Lymphoma (ICML) meeting (Abstract #007).
Novartis reported the interim analysis of the global multi-centre Phase II JULIET study which showed a 3-month Overall Response Rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a Complete Response (CR) and 8% achieving a Partial Response (PR), respectively. CR remained stable from three months through data cut off among the patient group. Among 51 patients with >3 month follow-up or earlier discontinuation, best ORR was 59% (95% CI, 44%-72%; P<0.0001) with 43% achieving CR and achieving 16% PR. CR and PR rates at 3 months were 37% and 8% respectively. Cytokine Release Syndrome (CRS) occurred in 57% of infused patients (17% grade 3, 9% grade 4); no CRS associated deaths occurred. No cerebral oedema was reported. Three patients died from disease progression, within 30 days of infusion. No deaths were attributed to CTL019. The abstract is available online here: http://onlinelibrary.wiley.com/doi/10.1002/hon.2437_6/full.
The overall response rate seen in this early analysis is impressive for these heavily pre-treated patients with relapsed/refractory DLBCL, who have limited treatment options. The full JULIET primary analysis is expected to be available later this year and will serve as the basis for US and EU regulatory submissions.
“We are pleased that Novartis has reported these additional strong data with CTL019 in another indication, r/r DLBCL, which is a much larger target patient population than for r/r ALL. We continue to work closely with Novartis in delivering the lentiviral vector across their CTL019 pipeline/franchise, a product group described earlier this year, by Novartis, as having “blockbuster” potential.”
John DawsonChief Executive Officer of Oxford BioMedica
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About Oxford BioMedica
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the “Group”) have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, Orchard Therapeutics and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 250 people. Further information is available at www.oxfordbiomedica.co.uk.